QEK — Angiographic Coronary Vascular Physiologic Simulation Software Class II
FDA product code QEK covers "Angiographic Coronary Vascular Physiologic Simulation Software", a Class II medical device regulated under 21 CFR 870.1415. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QEK
- Device Class
- Class II
- Regulation Number
- 870.1415
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.